EU/3/16/1701: Orphan designation for the treatment of hyperargininaemia
poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase)
Table of contents
Overview
This medicine is now known as pegzilarginase.
On 14 July 2016, orphan designation (EU/3/16/1701) was granted by the European Commission to ERA Consulting GmbH, Germany, for poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (also known as AEB1102) for the treatment of hyperargininaemia.
Key facts
Active substance |
poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase)
|
Intended use |
Treatment of hyperargininaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/16/1701
|
Date of designation |
14/07/2016
|
Sponsor |
Immedica Pharma AB |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Update history
Date | Update |
---|---|
November 2022 | The sponsor's address was updated. |
November 2021 | The sponsorship was transferred to Immedica Pharma AB, Sweden. |
August 2021 | The sponsorship was transferred to YES Pharmaceutical Development Services GmbH, Germany. |
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: